Protocol summary
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Study aim
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Determining the effect of gamification-based sexual conversation skill enhancement intervention on sexual compatibility and satisfaction in married students of Tehran University dormitories.
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Design
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The clinical trial has a control group and two intervention groups, randomized by lottery, without blinding, on 41 couples in each group, with a total of 123 couples.
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Settings and conduct
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The names of women aged 18 to 45 who are registered in 3 married dormitories of Tehran University are randomly placed in intervention group 1, intervention 2 and control group.
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Participants/Inclusion and exclusion criteria
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Reproductive age (18-45 years), married for more than one year, having a spouse and active sex, having Iranian nationality, having the ability to read and write, having a dedicated smart cell phone, no history of couples participating in sexual skill training courses and counseling In the past 2 months, the husband's participation and accompaniment in educational programs, no alcohol and drug use in the couple, no sexual dysfunction , no disabilities, no known chronic diseases، Lack of chronic psychiatric disorders and problems (self-reported)
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Intervention groups
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The couples of the intervention group 1 will play the sexual conversation skill game online once a week for one month and twice a week. The researcher will answer the questions raised by the people. In intervention group 2, women share brochure content with their husbands. No training is given in the control group.
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Main outcome variables
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Sexual satisfaction and sexual compatibility
General information
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Reason for update
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Due to the lack of organizational cooperation and lack of sufficient samples, the target population was changed from Tehran neighborhoods to married students of Tehran University dormitories.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220712055440N1
Registration date:
2022-09-25, 1401/07/03
Registration timing:
prospective
Last update:
2023-02-28, 1401/12/09
Update count:
1
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Registration date
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2022-09-25, 1401/07/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-03-11, 1401/12/20
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Expected recruitment end date
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2023-04-09, 1402/01/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of gamification-based sexual conversation skill-enhancing intervention on sexual satisfaction and compatibility in married students of Tehran University dormitories: a randomized clinical trial
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Public title
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the effect of intervention that promotes skill of sexual talk with spouse based on gamification on the level of sexual compatibility and satisfaction in married students
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Reproductive age (18-45 years)
Marriage duration more than one year
Having a spouse and active sex
Having Iranian nationality
Having the ability to read and write
Having a dedicated smart phone
Participation and companionship of the husband in educational programs
Exclusion criteria:
history of couples participating in sexual skill training and counseling courses in the last 6 months
sexual dysfunction (self-reported)
any disability (self-declaration)
suffering from known chronic diseases (self-reported)
chronic psychiatric disorders and problems (self-reported)
alcohol and drug use in couples
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
123
More than 1 sample in each individual
Number of samples in each individual:
1
Wives are also present in this research
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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3 dormitories of married students of Tehran University (according to the sample entry criteria) are randomly placed in intervention groups 1 and 2 and control by lottery.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-01-13, 1400/10/23
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Ethics committee reference number
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IR.TUMS.FNM.REC.1400.184
Health conditions studied
1
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Description of health condition studied
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Educational - advisory
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Sexual satisfaction score in the Larson questionnaire
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Timepoint
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The amount of sexual satisfaction before the start of the intervention and 4 and 8
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Method of measurement
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Larson questionnaire
2
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Description
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Sexual compatibility score in the questionnaire of sexual compatibility with spouse (Dr. Nekulal Tek et al.)
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Timepoint
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The level of sexual compatibility before the start of the intervention and 4 and 8
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Method of measurement
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questionnaire of sexual compatibility with spouse (Dr. Nekulal Tek et al.)
Intervention groups
1
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Description
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Intervention group:Intervention group 1 will play the sexual conversation skill game with each other (couples) twice a week for one month, and once a week the researcher will answer the questions raised online through WhatsApp. Questionnaires are completed before and 4 and 8 weeks after the intervention by both intervention groups.
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Category
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Behavior
2
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Description
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Intervention group:Intervention group 2, women share the content of the brochure that contains sexual conversation skills with their husbands. And the questionnaires are completed before and 4 and 8 weeks after the intervention by both intervention groups
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Study data can be shared after de-identifying individuals
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When the data will become available and for how long
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six months after publication of finding
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To whom data/document is available
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The data of this research will be accessible to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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The data obtained from this study will be accessible only to conduct similar studies
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From where data/document is obtainable
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Dr.Maryam Nekoolaltak-email:mnekoolaltak@sina.tums.ac.ir
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What processes are involved for a request to access data/document
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Initial correspondence via e-mail, face-to-face meeting and presentation of a work proposal similar to the current research, providing sufficient evidence for the similarity of your research with the current research, reading the proposal by the current research manager, making a decision and announcing the result by the current research manager, providing the researcher with access to data. Providing data files for on-site use.
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Comments
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